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National Advisory Council

The Council provides advice and recommendations to the Director, AHRQ, and to the Secretary, HHS, on priorities for a national health services research agenda.

Testimony on Comparative Effectiveness Research

Peter DeNucci, Apollo Publishing, Inc.

On April 3, 2009, public testimony on comparative effectiveness research was given at a meeting of the National Advisory Council for Healthcare Research and Quality. The testimony represents the views of the presenter and not necessarily those of the Agency for Healthcare Research and Quality (AHRQ) or the Department of Health and Human Services (HHS).

April 3, 2009

RE: Public Comment on Comparative Effectiveness Program funding by AHRQ

My name is Peter DeNucci, the president of Apollo Publishing, Inc. We are an ACCME accredited Florida-based Patient Safety Organization (PSO) dedicated to saving human lives by migrating aviation's best safety practices into healthcare. As a retired US Airways Captain, I was part of the pioneering team, which created the education program in that airline known as Crew Resource Management (CRM). CRM training and procedures can be directly attributed to the quick and skilled actions of both pilots and three flight attendants of US Airways Flight 1549 on January 15, 2009, in which Captain "Sully" Sullenberger successfully landed on the Hudson River saving 155 lives in the process. The entire flight crew performed exactly as trained in a very harsh environment to ensure the safety of every passenger. We know what went right, and why. Empower the leader with authority and tools to create a communicative environment and effectively form a team of people in stressful, high stakes conditions, thus, allowing Captain Sully to talk with his team, see everything, and be ready to address it. Just as this training helped facilitate zero-loss of life on the Hudson River, it can create the same cultures of safety and eliminate preventable medical errors in the healthcare industry today. If you pick up any medical journal today inevitably you will find a sufficient amount of articles and commentaries that point to the safety of commercial flying and human factors studies as a way to improve patient safety.

The aviation industry experienced a large number of deadly crashes throughout the 1980's and research by NASA found that 70% involved human factors, such as communication problems. As a result, the FAA implemented CRM as a means of achieving high levels of safety in an industry where safety is paramount. JCAHO estimated that over 70% of sentinel events reported stem from the same human factors issues (i.e., communication failure), whichreinforces the fact that hospitals need to implementformal training in teamwork for healthcare workers, similar to aviation's CRM to train pilots. In both of these industries, pilots and healthcare workers operate in complex environments; not only do teams interact with technology, but a human error can mean the difference between life and death.

Nearly ten years after the IOM milestone report, To Err Is Human, which estimated that as many as 98,000 people die in US hospitals each year due to preventable medical errors, is healthcare any safer now? The answer is: not really, we still pay a high price today, not only financially, but in lives lost or nearly lost. The cost of medical mistakes is shocking. JAMA (2003) reported $9.3 billion is spent every year for extra hospital days and unnecessary complications. More specifically, medication errors alone cost $3.5 billion and harm an estimated 1.5 million people a year (Patient Safety and Quality Healthcare, 2006).

Proven successful in the aviation industry to achieve a "zero-accident" standard, commander and crew leadership is foundational in healthcare to all therapeutic and clinical areas. From Apollo's standpoint, current prevention practices that focus on knowledge and technical skills training is unlikely to change the outcome of wrong-site surgeries, wrong-patient procedures, surgical counts errors, blood transfusion oversights, etc. Rather, Apollo's Commander and Crew CRM and human factors training offers a uniform approach to patient safety and addresses one of the major roadblocks—communication barriers. A team always needs to know who their leader is and that there is a safety system in place to "catch" potential errors. This proven curriculum (yes, there is a "science" to CRM and teamwork) is used to teach pilots how to maintain a clear-eyed perspective in their ever-changing, high-stakes environments. The healthcare industry and their patients can benefit from aviation's failures, their lessons learned, and their hard-earned success.

Apollo's innovative education/training program is leading the way in several hospitals and has taken our primary institution, Flagler Hospital, to the near-zero incident rate. The physicians and staff are going through a transformation similar to what pilots at US Airways went through 18 years ago. Following the new communication protocols (e.g., with the help of knowledgeable O.R. staff, Apollo designed a visual aid that continues to hang on the wall in the O.R. today and maintains the central elements of the time-out concept mandated by JCAHO1), a dramatic increase in surgeon led time-outs was observed, which is a most desirable physician attribute. In fact, effective time-out briefings given by the surgeon were conducted less than 3% of the time pre-Apollo, and increased to currently 100% mission completion post-Apollo. This result is not unusual, the same findings occurred almost immediately in aviation post-CRM. As a result of this improved communication and leadership from the surgeon, 100% elimination of wrong-site surgeries and surgical counts errors was also achieved.

Apollo's Commander and Crew CRM program was developed in an effort to accelerate the improvement of patient-centered care in healthcare nationwide through increased team efficiency and improved decision-making. Apollo's Commander and Crew CRM program teaches leadership responsibilities, how crews can avoid barriers to effective communication, and how to function well as teams to increase team efficiency and improve decision-making. The program includes instruction about human factors and human limitations and utilizes countermeasures such as effective crew briefings (i.e., universal protocol's "time-outs"), and Embedded Performance Tools (EPTs), such as standardized safety checklists, read-backs and verifications, and utilization of a common language. Patient safety is dramatically increasing, as healthcare professionals acquire the skill sets, tools, and language necessary to create a culture of safety within their own healthcare institution, thereby "culturing each other". Therefore, the medical community will continue to promote safe practices, enhance current safety training, and move the healthcare environment to a new ‘culture of safety' and away from the current ‘risk inherent' environment often experienced.

If the practice of CRM were more widely presented, the likelihood of lives lost due to preventable medical errors would be diminished and the patient would most certainly be on the receiving end of these benefits. In these worsening economic times, hospitals across the country are finding it more difficult to support training efforts. The risk of withholding safety training and information to the medical community is that patient care and safety is reduced. Supporting industries and organizations involved in promoting excellence in patient care recognize that no longer can we afford to do nothing. There is a critical need to save tens of thousands of lives affected by preventable medical mistakes each year across the country. So, there is no better time than right now for this funding, available through the American Recovery and Reinvestment Act of 2009, to find solutions to the illness plaguing healthcare and to restore the health of the many patients harmed when mistakes are made at the very hospitals that are supposed to help them. Let's put CRM in healthcare to the test! Assessing the outcomes, effectiveness, and appropriateness of CRM in healthcare will, at the very least, increase the confidence of those receiving medical care that hospitals actually make them better, not worse. Here, before us, we have the first opportunity of its kind to compare the effectiveness of evidence-based teamwork training strategies to determine if they can truly facilitate hospitals and healthcare workers to improve patient care and, in turn save patients' lives today and for the future.

Thank you,

Peter J. DeNucciPresident

1 In 2003, JCAHO began requiring hospitals to implement safe practices as part of what they call a universal protocol, including improving staff communications and calling for a "time-out" immediately before starting a procedure. The "time-out" concept is borrowed from the field of aviation, CRM "briefs" are "the fundamental establishment of the team, as a cohesive group" (DeNucci, 2005, p. 45). This crucial step sets the tone after the initial "flight plan" is developed. The commander clearly states the objectives of the mission, lays out the general direction for take-off, and calls out the first action items. Expected weather conditions are shared, as well as alternate routes. Finally, input is solicited from the crew members. Pilots are trained to recognize that crew members have vital information required to achieve the mission. Sharing procedures, asking questions, and enrolling the crew enables effective leaders to flatten the hierarchy and create trust and a safe environment for input and a willingness to speak up when they have safety concerns. The experts recognize that teams must work cooperatively and communicate effectively to achieve the common goal of safety.